Luvox

(Fluvoxamine)

ApprovedSmall molecule

Fluvoxamine is used to treat depression, anxiety disorders, and obsessive-compulsive disorder (OCD) by helping to balance chemicals in the brain that affect mood and behavior.[2] Luvox is currently approved and in use across 12 indications[4].[1]

Luvox is one of 333 small molecule programs targeting COVID-19. It is currently in Approved.

Indications

Total Trials

Active Trials

332

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

COVID-19Not yet recruiting

Panic DisorderApproved

Severe Acute Respiratory SyndromeApproved

Depressive DisorderActive, not recruiting

SchizophreniaActive, not recruiting

MorbidityCompleted

Acute Kidney InjuryActive, not recruiting

Bipolar DisorderActive, not recruiting

InsomniaActive, not recruiting

Treatment Resistant DepressionActive, not recruiting

COVID-19Phase 3

Not yet recruiting

Panic DisorderApproved

Approved

Severe Acute Respiratory SyndromeApproved

Approved

Depressive DisorderApproved

Active, not recruiting

SchizophreniaPreclinical

Active, not recruiting

MorbidityPreclinical

Completed

Acute Kidney InjuryPreclinical

Active, not recruiting

Bipolar DisorderPreclinical

Active, not recruiting

InsomniaPreclinical

Active, not recruiting

Treatment Resistant DepressionPreclinical

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Luvox

SSolvay Pharmaceuticals

Approved

9 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 3Recruiting

Delirium

NCT06969287

Phase 3Not yet recruiting

COVID-19

NCT07359482

Q3 2028

Recruiting

Lactating Women on Select DOI

NCT03511118

Q4 2028

Phase 2Recruiting

Obsessive-Compulsive Disorder

NCT04539951

Clinical

Trials by Indication[1]

COVID-199 trials

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm E (Fluvoxamine 100)

Completed·—·Phase 3·NCT05894564·1,208 enrolled

A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

Completed·WWashington University School of Medicine·Phase 2·NCT04342663·152 enrolled

Fluvoxamine for Adults With Mild to Moderate COVID-19

Suspended·—·Phase 2·NCT04711863·400 enrolled

Show 6 more trials

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)

Completed·—·Phase 3·NCT05890586·1,331 enrolled

COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)

Completed·UUniversity of Minnesota·Phase 3·NCT04510194·1,323 enrolled

Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients

Completed·SSigmaDrugs Research Ltd.·Phase 2·NCT04718480·66 enrolled

ACTIV-6: COVID-19 Study of Repurposed Medications

Completed·—·Phase 3·NCT04885530·10,956 enrolled

Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)

Completed·WWashington University School of Medicine·Phase 3·NCT04668950·670 enrolled

sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19

Not yet recruiting·—·Phase 3·NCT07359482·160 enrolled

Tics6 trials

Influence of Fluvoxamine on the Pharmacokinetics of BI 409306

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02853136·18 enrolled

Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03340662·81 enrolled

A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01665404·16 enrolled

Show 3 more trials

Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

Completed·KKarolinska Institutet·Phase 1·NCT01704638·14 enrolled

Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine

Completed·VVanda Pharmaceuticals·Phase 1·NCT01540500·24 enrolled

Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant

Completed·CCorcept Therapeutics·Phase 1·NCT05712265·26 enrolled

Interaction4 trials

Drug-Drug Interaction (DDI) Study for TD-9855

Completed·TTheravance Biopharma·Phase 1·NCT03432793·41 enrolled

AV650 Drug-Drug Interaction Study

Completed·AAvigen·Phase 1·NCT00456560·30 enrolled

Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects

Completed·AAsceneuron S.A.·Phase 1·NCT06232109·50 enrolled

Show 1 more trial

Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464

Completed·AAbivax S.A.·Phase 1·NCT05121714·59 enrolled

Anxiety2 trials

Treatment for Anxiety in Children

Completed·NNational Institute of Mental Health (NIMH)·Phase 3·NCT00000389

Treatment of Youth With ADHD and Anxiety

Completed·NNational Institute of Mental Health (NIMH)·N/A·NCT00012584·120 enrolled

Major Depressive Disorder2 trials

Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics

Unknown status·SShanghai Mental Health Center·Phase 4·NCT03219008·800 enrolled

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Unknown status·SShanghai Mental Health Center·Phase 4·NCT01764867·1,080 enrolled

26 more indications

Cognitive Function2 trials

Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine

Completed·—·Phase 4·NCT02016261·50 enrolled

Genetic Expression in Schizophrenics Treated With SSRI Augmentation: Relationship to Clinical and Cognitive Function

Unknown status·SSha'ar Menashe Mental Health Center·N/A·NCT00645580·15 enrolled

Clopidogrel2 trials

Impact of Citalopharm and Fluvoxamine on Platelet Response to Clopidogrel

Completed·HHadassah Medical Organization·Phase 1·NCT01396720·15 enrolled

Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel

Completed·HHadassah Medical Organization·Phase 1·NCT01269333·15 enrolled

Smoking1 trial

A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04478513·28 enrolled

Morbidity1 trial

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Completed·UUniversity of Washington·N/A·NCT02655354·635 enrolled

Insomnia1 trial

The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia

Unknown status·GGuang Dong Provincial Mental Health Institute·N/A·NCT02442713·30 enrolled

Long COVID-191 trial

Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05216614

Delirium1 trial

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

Recruiting·WWashington University School of Medicine·Phase 3·NCT06969287·46 enrolled

Schizophrenia1 trial

Effect of Fluvoxamine on Cognition, Behavior, Symptoms and mRNA and Protein Expression in Schizophrenia Patients

Unknown status·SSha'ar Menashe Mental Health Center·N/A·NCT01832285·40 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Autism1 trial

Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?

Completed·TThe Hospital for Sick Children·Phase 3·NCT00655174·108 enrolled

Melancholia1 trial

A Clinical Trial of Fluvoxamine for Melancholia

Unknown status·LLingjiang Li·Phase 2·NCT04160377·150 enrolled

Pomalidomide1 trial

A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01707407·32 enrolled

Acute Kidney Injury1 trial

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02320240·3,255,526 enrolled

Caffeine1 trial

To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers

Completed·KKaken Pharmaceutical·Phase 1·NCT06821698·38 enrolled

Treatment Resistant Depression1 trial

Interpersonal Psychotherapy for Treatment Resistant Depression

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT01896349·74 enrolled

Systemic1 trial

Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03930602·16 enrolled

Elective1 trial

Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

Completed·AAzienda Ospedaliera Universitaria Integrata Verona·Phase 4·NCT03779789·362 enrolled

Prevention1 trial

Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Completed·SShanghai Mental Health Center·Phase 4·NCT02022709·78 enrolled

TED1 trial

Risk of CYP2C19 Phenoconversion in Healthy Volunteers With Rapid, Normal, and Intermediate Predicted Metabolizers' Status

Unknown status·UUniversity Hospital, Geneva·Phase 1·NCT05264142·45 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.

Completed· Novartis logo

Novartis·Phase 1·NCT01700270·45 enrolled

ESS1 trial

A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05888207·16 enrolled

Obsessive-Compulsive Disorder1 trial

Pragmatic Trial of Obsessive-compulsive Disorder

Recruiting·SShanghai Mental Health Center·Phase 2·NCT04539951·1,600 enrolled

Concentration1 trial

Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT01908296·24 enrolled

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Long COVID1 trial

Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial

Completed·WWashington University School of Medicine·Preclinical·NCT05874037·191 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 5, 1994

LUVOX

NDA NDA020243

Dec 20, 2007

LUVOX

NDA NDA021519

Feb 28, 2008

LUVOX CR

NDA NDA022033

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for Fluvoxamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Luvox drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fluvoxamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fluvoxamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022033). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Solvay Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSolvay Pharmaceuticals

Luvox

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q3 2028

Q4 2028

Trials by Indication[1]

COVID-199 trials

Tics6 trials

Interaction4 trials

Anxiety2 trials

Major Depressive Disorder2 trials

Cognitive Function2 trials

Clopidogrel2 trials

Smoking1 trial

Morbidity1 trial

Insomnia1 trial

Long COVID-191 trial

Delirium1 trial

Schizophrenia1 trial

Bipolar Disorder1 trial

Autism1 trial

Melancholia1 trial

Pomalidomide1 trial

Acute Kidney Injury1 trial

Caffeine1 trial

Treatment Resistant Depression1 trial

Systemic1 trial

Elective1 trial

Prevention1 trial

TED1 trial

Patients With Advanced Solid Tumors1 trial

ESS1 trial

Obsessive-Compulsive Disorder1 trial

Concentration1 trial

Lactating Women on Select DOI1 trial

Long COVID1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News